F.D.A. Seeks to Toughen Defibrillator Regulations

WASHINGTON — The Food and Drug Administration said Friday that it was moving to toughen regulation of the industry that produces heart defibrillators — devices used to jolt a failing heart back into its regular rhythm — after tens of thousands of malfunctions and hundreds of deaths in recent years.

In one case, a nurse was trying to hook up a defibrillator to a patient in cardiac arrest when its electronic screen read “memory full” and then shut down, according to one example provided by the F.D.A. The patient soon died. In another case, a software defect caused the device to show an “equipment disabled” message. That patient also died.

The devices, which can be found in malls, airports, casinos and churches in addition to medical settings, re-establish cardiac rhythms in patients whose hearts have abruptly stopped or lost their regular beats. Such cardiac arrests kill as many as 400,000 people a year in the United States, according to the American Heart Association, more deaths than caused by Alzheimer’s disease, diabetes and accidents combined.

There have been 45,000 reports of the devices failing or malfunctioning since 2005, agency officials said. The vast majority of them were due to manufacturing problems, officials said, but some were because of improper maintenance, like battery failure. Manufacturers have recalled the devices 88 times in that period.

The problems led the agency to propose a change that would allow it to more closely monitor how the devices — known as automated external defibrillators, or A.E.D.’s — are designed and made. There are about 2.4 million of them in public places across the country.

Dr. William Maisel, chief scientist at the F.D.A.’s Center for Devices and Radiological Health, said in a conference call with reporters on Friday, “We think tens of thousands of adverse events is too many and 88 recalls is too many.”

On Friday, the agency issued an order that, if made official after a public comment period, would require manufacturers to submit details of their designs and the controls they use in buying defibrillator components, many of which are produced abroad. Regulators would also be able to inspect manufacturers’ factories.

Normally, for devices regulated under this framework, manufacturers would have to conduct costly and time-consuming clinical trials, but Dr. Maisel said that most of the manufacturers have already collected the data that such trials would produce, and that only a couple would need to carry out such studies.

After a 90-day public comment period, companies will have another 90 days to file their paperwork. The agency will give companies an additional 15 months to comply with the changes. An F.D.A. official said she expected the process to be complete by the end of 2014.

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There are about 2.4 million defibrillators in public places nationwide.Credit...Tim Boyle/Getty Images

A spokeswoman for Philips, one of the manufacturers, said the change would not interrupt distribution, but she added that the company needed to review the F.D.A. order before commenting on whether future supplies would be affected.

Another major manufacturer, Physio-Control, in Washington State, said in a statement that it was “extremely confident in our ability to meet these new regulations, if adopted.” A spokesman said the change would be more difficult for smaller manufacturers, because more resources would be required to follow the rules.

Death rates from cardiac arrests have changed little since the 1980s, when defibrillators first became widely available to the public. Experts say those statistics could improve if more of the devices were accessible to more people. Bystanders use them in just 5 percent of cardiac arrests, according to data from the Emory University School of Medicine, in part because patients usually become ill in private homes where there are no defibrillators.

Dr. Mickey Eisenberg, the emergency medical services director for King County in Seattle, said he worried the changes would hinder innovation, which he said was critical to better use of the devices and could lead to fewer deaths. The price of defibrillators, which cost $1,000 to $2,000, needs to drop, he said, to make them affordable for home use, a bit like a fancy smoke detector.

“A.E.D.’s in public places will never solve the problem,” he said. “They need to become consumer items, to enter people’s bedrooms and homes.”

Even for manufacturers that would not be required to conduct clinical trials, the cost of complying with the new regulations would rise to about $220,000 from about $5,000, according to Dr. Maisel. He said that companies with multiple models would have to pay that money only once, and that the sum could also be applied to subsequent versions.

Elliot Fisch, the president of Atrus, which provides defibrillator location information to dispatch agencies during cardiac arrest calls, said cost increases could be passed on to the consumer and make the devices less affordable. He said survival rates have improved sharply in recent years in Seattle, in part because defibrillators are more easily accessible.

“If this is going to increase costs to where it becomes prohibitive for organizations to purchase them, that’s not good, because the biggest problem is access,” he said.

But Dr. Gordon Tomaselli, chief of cardiology at Johns Hopkins University and a past president of the American Heart Association, said the F.D.A.’s move could boost confidence in the devices and encourage their use.

“People already have a lack of comfort in using these devices,” he said. “If word is out there that they don’t work anyway, people will be even more reluctant to do something that they were pretty nervous about to begin with.”